Blood donor assembly



Sept. 21, 1954 ADAMS r 2,689,562

BLOOD DONOR ASSEMBLY Filed May 15, 1951 3 Sheets-Sheet l lNVENTOiRS :DMMLLK ATTORNEYS Sept. 21, 1954 J. ADAMS ET AL 2,689,562

BLOOD DONOR ASSEMBLY Filed May 15, 1951 3 Sheets-Sheet 2 Ill/l lI/IIIIII/IIL /I r W ,U,"

INVENTORS 101m (2 flda ms fix 111117141!!! D uLU/ M4. K L ATTORNEYS p 1954 J. Q. ADAMS ETAL 2,689,562

BLOOD DONOR ASSEMBLY Filed May 15, 1951 3 Sheets-Sheet 5 All /A INVENTORS IE ht 6. fldams y Jase 4k [Klan/r Patented Sept. 21, 1954 BLOOD DONOR ASSEMBLY John Q. Adams, Rutherford, N. J and Joseph J. Kleiner, Woodmere, N. Y., assignors to Becton, Dickinson and Company, Rutherford, N. J., a corporation of New Jersey Application May 15, 1951, Serial No. 226,462

Claims.

This invention relates to a structurally and functionally improved assembly used in connection with blood donation and transfer; the present apparatus being also capable of use with liquids other than blood and certain of the elements thereof being useful apart from the assembly.

It is an object of the invention to furnish apparatus of this nature and in which a sterile assembly will be instantly available for use. After such use (which may involve either a single operation or a series of steps) the apparatus may conveniently be discarded if it is impracticable or undesirable to clean and sterilize the parts of the same for reuse.

An additional object is that of providing a cannula or needle as part of the assembly; this unit being capable of a ready manipulation although it may at all times, when not in use, be maintained in a housed or protected condition.

Still another object is that of designing an apparatus which may be readily and economically manufactured; the several components of the assembly being capable of ready connection to each other to furnish a unitary apparatus which may be employed with facility.

With these and other objects in mind, reference is had to the attached sheets of drawings illustrating practical embodiments of the invention and in which: i

Fig. 1 is a sectional side view of the upper end of a sealed container and showing the penetrating cannula moved to a point adjacent to same;

Fig; 2 illustrates the cannula prior to its initial stage of seal penetration;

Fig. 3 shows the cannula extending completely through the seal;

Fig. 4 illustrates the manipulationof the cannula assembly after its removal from the seal;

Fig. 5 is a sectional side view of that assembly and illustrating in section a 'vena needle associated therewith;

Fig. 6 is a perspective view of these assemblies but showing an alternative form of hub design as well as a manipulating plate;

Fig. 7 is a fragmentary perspective view showing the manipulating plate detached from the cannula hub;

Fig. 8 is a sectional side view of an alternative form of puncture needle assembly;

Fig. 9 is a front view of a holder preferably used with this assembly;

Fig. 10 is a side view of the holder with the assembly mounted thereon and in process of application to a receptacle; and

Fig. 11 is a fragmentary view of the receptacle and assembly and with the blood in course of transfer to the receptacle.

Reference is primarily had to Fig. 5 in which both needles of the assembly have been illustrated. The seal-puncturing needle is to be initially considered. Thus, the numeral l0 indicates a hollow needle provided at its outer end with the usual penetrating point. The opposite end of the needle is surrounded with a hub structure conveniently embracing a flange or hub portion II and a gripping portion, which as in Figs. 1 to 4 may be in the form of a truncated cone I2 conveniently having its outer face formed with a series of grooves l3. The hub H is sep-' arated from the cone l2 by a neck l4 integral with both of these parts. The entire hub assembly is, of course, secured in any desirable and acceptable manner against movement with respect to the cannula Hi. The latter projects beyond the rear of the hub assembly.

That end of the cannula which extends forwardly of the hub assembly is enclosed in a sheath or cap l5 formed of rubber or any other proper material. The length of the cap should be in excess of the enclosed needle portion. The outer end of the cap is sealed as at I6. Its opposite end is mounted against detachment from the hub assembly by conveniently extending over the portion II into the groove provided by the reduced neck portion 14. The rear end of the cannula is ensleeved by theend of a tube I1. The latter is preferably a vinyl plastic tubing and has a normal bore diameter substantially identical with the bore of needle H). The end edge of the tubing may abut the outer end of cone 12.

Now considering the intravenous needle shown in Figure 5 it will be noted that the body of the same is indicated at 18. This needle is provided with the usual pointed outer end portion embodying any acceptacle type of structure. At a point suitably spaced from this end it is encircledby a hub assembly. The latter preferably includes a flange l9 and an enlarged rear portion 20 provided with a groove 2 l. The flange I 9 and rear portion are connected by an integral reduced neck portion 22. The end of tubing ll opposite to that connected to needle I0 is connected to the portion of cannula it which projects rearwardly of its hub assembly. The bore of cannula I8 is preferably the same diameter as the bore of cannula [0. Therefore, in efiect a continuous uninterrupted passage of constant diameter will extend from the pointed end of one needle through to the pointed end of the second needle.

Needle i 8 is protected by being enclosed in a sheath or cap 23. The latter may be formed of any suitable material such as vinyl tubing. Its length is such that it conveniently extends substantially beyond the pointed end of needle [8 when its opposite end extends into the reduced neck portion 22 and encloses flange 9. The outer end of the sheath 23 may be obstructed by a plug 24 conveniently of cotton and saturated with alcohol if desired.

As is well understood by physicians and others skilled in the art, it is customary to extend one needle or" a set into the vein of the donor. The opposite needle of that set is caused to penetrate a seal for a container, the interior of which is conveniently evacuated. Such a container has been shown in Figs. 1 and 6 and indicated by the reference numeral 25. It is provided with a neck portion conveniently furnished with an outer thread 25. The mouth or bore of this neck is sealed by a stopper embracing a body 21 and a head 23. This stopper may be formed of rubber or other proper materials but in any event should embody resiliency. It is provided in its upper and lower faces with aligned recesses 29 and 30 as well as 31 and 32. The bases of these recesses are separated by partitions or diaphragm portions 23 which are relatively thin and disposed in a zone such that they will lie below the pouring lip of receptac e 25 when the stopper is in fully seated position. So seated, that stopper will be under radial compression. Therefore, any perforations of minor size through the diaphragm portions will substantially seal upon withdrawal of the needle which has perforated them.

As heretofore described in connection with Fig. 5 the hub shown in the lower portion of that figure associated with the intravenous needle. A similar hub may be associated with the stopper-perforating needle as shown in Figs. 6 and 7. Thus, in these figures the numeral 34 indicates a hub portion formed with a groove 35 and a reduced part 36 over which the inner end of the sheath or cap 3'5 is ensleeved. A plate 38 for-med with a notch 39 may be provided as part of the assembly. The width of notch 39 is such that it may ride into groove 35. So positioned it will serve as a handle the end portions of which may be grasped between the thrumbs and foreof both hands to withdraw the stopperperforating needle 6d from the body of the sealing member closing receptacle 25 and also to extend that needle through the sealing member.

In this manner no difficulty will be experienced in furnishing a gripping portion permitting of the ready manipulation of this needle. As is obvious the plate may readily be detached from the needle hub whenever necessary. Also as shown in these views the hub .of the intravenous needle ll may, if necessary, be plain or knurled. The hub will provide a manipulating part for that needle. The two needles are connected by tubing it as heretofore described in connection with Fig. 5.

It will be understood that the parts of this assembly are manufactured in accordance with acceptable procedures. They are cleaned, sterilized and connected. So assembled an apparatus furnished in which all essential parts are adequately protected against contamination. In sterilizing, the plug 24 will permit of the escape of steam and heated air from the needle and tube bores. At any time the physician or other technician desires to employ the apparatus it will be instantly available for use. All that will be 4 necessary is for the user to remove the assembly from its package and if a receptacle such as 25 is employed, to remove the cap or other covering (not shown) which maintains the sterility of the upper surface of stopper head 28. this the procedure will be as follows:

The site of the vena puncture is selected and the surface is sterilized in accordance with acceptacle technique. If employed, the sheath 23 is stripped from the needle I8 and the latter is inserted into the vein. Due to the normal pressure of blood in the vein and the compressibility of air the blood will flow through the bore of cannula it and into tube 5?, a distance of around 4" to 5". Because of the translucent nature of tube H this will be readily apparent to the user. No clamp will be necessary to prevent the blood from flowing into the tube ll to a greater length or height because air may not escape from needle is and sheath I5.

With the removal of the cap or other covering from the neck of receptacle 25 the sterile face of stopper 28 is exposed. If desired, that face may be further sterilized. In any event, if the assembly embraces the parts as in Figs. 1 to 4 and with cap I5 in position on the needle as shown in Fig. 1, the point of that needle is brought to a position overlying diaphragm 33 at the base of recess 29. Sheath 55 will not enter that recess. Rather, it will tend to fold or extend angularly with respect to the axis of needle [0 as shown in Fig. 2. Therefore, continued pressure upon the hub of the puncturing needle will force the point of that needle to penetrate the sheath or cap 15 and to thereupon penetrate diaphragm 33. Under these circumstances the sheath will in effect be collapsed as shown in Fig. 3. During this projection of the parts it is apparent that if a conical hub portion i2 is provided, the operators will easily grip the same and be able to force the parts to the desired positions. So shifted they will remain in those positions because the resiliency of the sheath $55, as it seeks to reestablish initial position, will be far less than the res tance to movement which occurs due to the frictional contact between the outer face of cannula Ill and the surfaces of the diaphragm 33. Portions l2 and i3 of the hub structure will also serve as manipulaing parts to permit of the withdrawal of the needle from the position shown in Fig. 3 to that illustrated in Fig. 4. In the latter figure, it will be observed that the fingers of the operator may grip the end of the cap and stretch the same. Under these circumstances, the point of the needle will withdraw from the perforation in the cap and be completely housed and substantially sealed within the latter. I

As will be understood, when the point of needle !0 penetrated sheath 15 th bore of thecannula was exposed to atmospheric pressure. Therefore, under the pressure within the vein, the blood was free to rise or flow within tube ll from needle 98 towards needle It. Immediately after puncturing the cap or seal IS the point of needle iii penetrated diaphragm 33 at the baseof recess 29. Therefore, before blood was discharged from needle I ll the end of that needle was in communication with the interior of the vessel '25 as shown in Fig. 3. The body of thatve'ssel being under vacuum, the flow of blood would, if anything, accelerate through the tube ll. The parts are left in these positions until a desired amount of blood has been taken. When this has occurred either by grasping the needle hub or using a Beyond plate such as 38, needle I is withdrawn from association with the stopper or other seal. Diaphragm portion 33 being under radial compression it follows that the perforation in the latter will be self-sealing. When cap has been manipulated as in Fig. 4, needle I0 is enclosed in the cap. If desired a series of. tubes or other receptacles may now be employed for the purpose of taking terminal blood samples. These are conveniently closed by stoppers similar to that aforedescribed. It will be understood that if any substantial delay is encountered in taking these samples the enclosing of needle [0 by the sheath will prevent coagulation or leakage.

In taking terminal blood samples it is, of course, not necessary to enclose needle within the sheath in the manner shown in Fig. 4 if an undesirable time interval does not elapse. However, in addition to protecting that needle from contamination the sheath will-as afore brought outprevent continuing discharge of blood from the vein when such sheath encloses the needle. Upon the conclusion of the operation, needle 10 is withdrawn from the final stopper or seal. Thereupon needle [8 is withdrawn from the vein. As will be appreciated by employing tubing H of the character described hemolysis is reduced. This will be because in effect a single continuous passage free from constriction and enlargements is provided from the outer end of one needle through to the outer end of the second needle. Therefore,

the blood in flowing through this passage will not be buffeted and subjected to accelerated as well as retarded flows with consequent detriment to the blood discharged into receptacle 25 or other receptacles.

The purpose of recesses 3l-32 and any other recesses through the stopper 28 will be apparent in that one or more vents, tube connections or other expedients may thus be provided and by means of which the contents of the receptacle may be caused to fiow as desired. As will finally be understood, the tubing connecting the two needles is preferably formed of that type of plastic which when expanded tends to return to its normal position. Therefore, a tight seal is provided between the needles and the tubing. Additionally, the bores of all three are substantially constant throughout the entire assembly. The shrinking may be assisted by employing heat if desired.

In Figs. 8 to 11 an alternative and in certain respects preferred form of structure has been illustrated. Referring primarily to Fig. 8, it will be seen that the stopper-penetrating needle or cannula 40 may be enclosed in a sheath of protective material 4|. This sheath or cap is conveniently provided by a suitable plastic which will have resiliency such that its open end constricts around and frictionally engages those portions of the cannula assembly which are adjacent the hub. The latter as afore described is formed with a groove which in this view has been indicated by the reference numeral 42. As previously taught, the rear end portion 43 of the cannula is connected by a tube 44 with the vena needle.

A needle manipulating holder and clamp has been shown in Figs. 9 and 10. This is conveniently formed of metal and includes a base plate 45 formed with a notch 46 of a width such that it may accommodate the grooved portion 42 of the needle. Extending upwardly from this plate is a portion 41 formed with a tapered slit 48. The upper end of the latter has its edges diverging and separated a distance such that tube 44 may readily be accommodated therein. When this tube is moved downwardly into the slit it is pinched or constricted to a point where no flow of fluid may occur through it. The stopper-penetrating needle together with the holder have been shown in Fig. 10. Also in that view tube 44 has been shown in a position within the slit where it is properly constricted.

In using an assembly of this nature needle as has th grooved portion 42 of its hub inserted into notch 46. A portion of tubing 44 adjacent this cannula would then be disposed within the slit 48 and wedged by the edges of the latter so as to prevent any flow of fluid through tube 44. Thereupon, if cap 4| is used it may be removed and plate is grasped between the thumbs and index fingers of both hands. By exerting a steady straight pressure down on the selected site of stopper 49 the latter will be penetrated by the needle. The holder remains in association with the needle so that the flow through the assembly may be controlled. A receptacle 50 which is sealed by this stopper may, in common with the receptacle 25, contain any desirable material such as acid citrate dextrose. This will act as a preservative, anticoagulant and feeding agent for the blood. The receptacle 50 is now inverted as indicated in Fig. 11 and properly supported. When the vein has been punctured by the needle connected to the opposite end of tube 44, that tube 44 is removed from clamping engagement with the slit or slot 48. Under these circumstances blood will flow to the receptacle. Such flow will be accelerated incident to the vacuum existing within'that receptacle. However, as indicated in Fig. 11, the blood will merely bubble to the surface of the body of liquid 5| within the same and will not spurt into contact with the receptacle surfaces, upon which it would tend to coagulate. A lack of spurting will be because, with a substantial constant bore existing from the vena needle through to and including the stopper-penetrating needle, there will be no tendency for the latter to act as a nozzle and for surges to occur within the tube assembly.

After the desired quantity of blood has been withdrawn tube 44 is again disposed in clamping relation with the edges of slit 48. Holder plate 45 has its notch disposed in line with groove 42 and the needle is coupled with that holder. By placing the index finger of each hand under the opposite ends of the plate a gentle steady pull may be exerted to withdraw the needle from the stopper. The latter as afore brought out is preferably self-sealing. The holder may remain on the needle until terminal bloods are taken. After this operation has been completed the intravenous needle is withdrawn. The holder is removed from the needle 40 and the latter together with its connected tube and vena needle are discarded. Thus, among others, the several objects of the invention as aforenoted are achieved. Obviously numerous changes in construction and rearrangement of the parts might be resorted to without departing from the spirit of the invention as defined by the claims.

We claim:

1. In a blood donor assembly in combination a stopper-puncturing needle, a hub secured to said needle at a point intermediate its ends, a sealing cap of resilient material mounted by said hub and enclosing said needle, the needle being hollow and having a rear end portion extending beyond said hub, one end of a tubing of a bore substantially equal to the bore of said needle being secured to the rear end of said needle, an intravenous needle also having a rear end portion, the second end of said tubing being secured to the rear end portion of said latter needle and the bore of the latter being substantially equal to the bore of said tubing and a vented cover enclos ing said intravenous needle.

2. A blood donor assembly including in combination a pair of hollow pointed needles each having constant exterior and bore diameters, hub portions extending from each of said needles at positions intermediate the needle ends, a flexible tube having its opposite ends ensleeved over those ends of the needles which are opposite the points of the latter, the tube ends terminating short of the needle hubs, th zones of the tube ensleeved over the needle ends being enlarged and the fluid conducting bores of both needles and said tube being substantially equal in diameter and free from obstruction from the pointed end of one needle through to the corresponding end of the second needle.

3. An assembly as specified in claim 2 and in which at least one of said hubs is formed with a transverse groove to receive the edges of a needle-manipulating plate.

4. A blood donor assembly including in combination a flexible tube of substantially circular cross-section, a hollow stopper-puncturing needle, a hollow vena needle, said needles having pointed outer ends and the rear ends connected one to each of th opposite ends of said tube, the bores of both said needles and said tube being all unobstructed, substantially equal to each other and constant throughout the length or" said assembly, a hub secured to said puncturing needle at a point intermediate its ends, said hub being formed with a groove and a substantially rigid flat manipulating plate formed with a notch between its opposite end edges, the groove of said hub receiving the edges of said notch and the ends of said plate extending beyond said hub to furnish manipulating portions to be gripped by theoperator to effect axial movement of said needle.

5. A blood donor assembly including in combination a flexible tube of substantially circular cross-section, a hollow stopper-puncturing needle, a hollow vena needle, said needles having pointed outer ends and rearends connected one to each of the opposite ends of said tube, the bores. of both of said needles and said tube being all unobstructed, substantially equal to each other and constant throughout the length of said assembly, a hub secured to said puncturing needle at a point intermediate its ends and said hub being formed with a groove to detachably receive a manipulating plate.

References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 766,204 Walsh Aug. 2, 1904 1,050,042 Sellar Jan. 7, 1913. 2,057,726 Landis 1 Oct. 20, 1936- 2,222,371 Nesset Nov. 19, 1940 2,231,418 Trotter Feb. 11, 1941 2,256,657 Swabacker Sept. 23, 1941 2,261,065 Kirchner Oct. 28, 1941 2,276,421 Ross Mar. 17, 1942 2,309,302 Butler et al Jan. 26, 1943 2,362,537 Butler 1- Nov. 14, 1944 2,367,806 Shaw Jan. 23, 1945 2,410,546 McC'abe Nov. 5, 1946 2,442,983 Nesset June 8, 1948 2,452,644 Fields Nov. 2, 1948 2,461,558 Meagher Feb. 15, 1949 2,581,331 Ryan et a1. Jan. 1, 1952 2,638,897 Poitras May 19, 1953 FOREIGN PATENTS Number Country Date 452,825 Great Britain Aug. 31, 1936 567,078 France Nov. 30, 1923 573,611 Great Britain Nov. 28, 1945 587,280 Great Britain Apr. 21, 1947 OTHER REFERENCES Catalog of BD Products, Becton Dickinson and Co., Rutherford, N. J., 1935, page 12 relied upon. Copy in Div. 55.

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